Pradaxa® (dabigatran etexilate, 150mg bid) shows significant reduction in the risk of stroke over warfarin in patients with atrial fibrillation taking antiplatelet or other co...

Paris, France, 28 August 2011 – New data from two RE-LY® trial sub-group analyses show that dabigatran etexilate 150mg bid consistently reduces the risk of stroke in atrial fibrillation (AF) compared to well-controlled warfarin, irrespective of whether patients use antiplatelet ¹ or other concomitant therapies, such as the anti-arrhythmics amiodarone or verapamil. ² The relative benefits of dabigatran etexilate over well-controlled warfarin in the overall results of RE-LY® ^3,4 were consistent across patients using these concomitant treatments . ^1,2 The data was presented at the European Society of Cardiology (ESC) Congress 2011, in Paris, France.

Dabigatran etexilate 150mg bid is the only novel oral anticoagulant approved for stroke prevention in AF shown superior to well-controlled warfarin (median TTR 67% ^5,6) in an intention to treat analysis. ^3,4 These groundbreaking results were demonstrated in RE-LY®, a PROBE trial (prospective, randomized, open-label with blinded endpoint evaluation), comparing two fixed doses of the oral direct thrombin inhibitor dabigatran etexilate (110mg and 150mg bid) each administered in a blinded manner, with open label warfarin. ^3,7

The new findings are significant because the long time standard of care warfarin is known to interact with numerous medications, including many common co-medications metabolised via the Cytochtrome P450 pathway. In addition, approximately one in five patients with AF are being prescribed antiplatelet therapy alongside warfarin for conditions such as coronary artery disease, acute coronary syndrome, or recent coronary artery stenting. ⁸ The safety of antiplatelet therapy in combination with anticoagulants has been a physician concern, with the combination shown to increase major bleeding over the use of anticoagulation alone. ⁸